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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceDORNIER UROWAVE MICROWAVE THERMOTHERAPY SYSTEM
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantDornier MedTech America, Inc.
1155 ROBERTS BLVD.
KENNESAW, GA 30144
PMA NumberP970044
Date Received09/08/1997
Decision Date05/29/1998
Withdrawal Date 07/23/2002
Product Code MEQ 
Docket Number 98M-0403
Notice Date 06/23/1998
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
This device is indicated as a non-surgical treatment alternative to transurethral resection of the prostate (TURP) for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with prostatic lengths between 30 mm and 55 mm.
Supplements:  S001 S002 S003 
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